Effect of Nutrition Ingredients on Microbiota Modulation

NCT ID: NCT03668964

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2019-07-15

Brief Summary

The objective of this study is to evaluate in healthy volunteers the time-dependent effect of daily consumption for four weeks of six different nutrition ingredients on relative abundance of microbial taxa in fecal samples. Second, the study looks at the time-dependent effect of six different nutrition ingredients on alpha and beta diversity of microbiota in fecal samples. Moreover, the time-dependent effect of six different nutrition ingredients on gastrointestinal symptoms and quality of life will be measured.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin B2

Daily dose of 75 mg Vitamin B2

Group Type: EXPERIMENTAL

Vitamin B2

Intervention Type: DIETARY_SUPPLEMENT

One capsule of 75 mg Vitamin B2 once a day for 4 weeks

Vitamin C

Daily dose of 500 mg Vitamin C

Group Type: EXPERIMENTAL

Vitamin C

Intervention Type: DIETARY_SUPPLEMENT

One capsule of 500 mg Vitamin C once a day for 4 weeks

Vitamin B2 + C

Daily dose of 75 mg Vitamin B2 and 500 mg Vitamin C

Group Type: EXPERIMENTAL

Vitamin B2 + C

Intervention Type: DIETARY_SUPPLEMENT

One capsule of of 75 mg Vitamin B2 plus 500 mg Vitamin C once a day for 4 weeks

Vitamin A

Daily dose of 250 µg Vitamin A

Group Type: EXPERIMENTAL

Vitamin A

Intervention Type: DIETARY_SUPPLEMENT

One capsule of 250 µg Vitamin A once a day for 4 weeks

Vitamin D3

Daily dose of 60 µg Vitamin D3

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

One capsule of 60 µg Vitamin D3 once a day for 4 weeks

Vitamin E

Daily dose of 100 mg Vitamin E

Group Type: EXPERIMENTAL

Vitamin E

Intervention Type: DIETARY_SUPPLEMENT

One capsule of 100 mg Vitamin E once a day for 4 weeks

Placebo

Daily dose of 575 mg microcrystalline cellulose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

One capsule of 575 mg microcrystalline cellulose once a day for 4 weeks

Interventions

Vitamin B2

One capsule of 75 mg Vitamin B2 once a day for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Vitamin C

One capsule of 500 mg Vitamin C once a day for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Vitamin B2 + C

One capsule of of 75 mg Vitamin B2 plus 500 mg Vitamin C once a day for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Vitamin A

One capsule of 250 µg Vitamin A once a day for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3

One capsule of 60 µg Vitamin D3 once a day for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Vitamin E

One capsule of 100 mg Vitamin E once a day for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

One capsule of 575 mg microcrystalline cellulose once a day for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Riboflavin; Cholecalciferol; alpha-tocopherol

Eligibility Criteria

Inclusion Criteria

1. Subjects willing and able to give written informed consent and to understand, to participate and to comply with the clinical study requirements;

2. Be between 20 and 50 years of age;

3. Has a BMI of between 18.5 - 30 Kg/m2;

4. Has a stable body weight (< 5% change) over the past 3-months;

5. Is in general good health, as determined by the investigator;

6. Willing to avoid consuming dietary supplements, prebiotic, probiotic, dietary or fibre rich supplements within 4 weeks prior to baseline visit, until the end of the study;

7. Willing to avoid liver consumption during the intervention

8. Maintain current level of physical activity;

9. Women of child-bearing potential using a non-hormonal contraceptive (e.g. IUD);

10. Willing to consume the investigational product daily for the duration of the study.

Exclusion Criteria

1. Females are pregnant, lactating or wish to become pregnant during the study.

2. Are hypersensitive to any of the components of the test product;

3. Has taken antibiotics within the previous 3 months;

4. Has a history of drug and/or alcohol abuse at the time of enrolment;

5. Consumes greater than 2 servings/day of alcohol (e.g. >28 g ethanol/day);

6. Is a smoker;

7. Has made any major dietary changes in the past 3 months;

8. Subject is planning a sun or ski holiday over the duration of the study;

9. Planned major changes in life style (i.e. diet, dieting, exercise level, travelling) during the duration of the study;

10. Has an eating disorder;

11. Is vegetarian/vegan diet or has food allergies or other issues with foods that would preclude intake of the study products;

12. Is using fibre supplements or enemas;

13. Has a high fiber diet (i.e. >30 g) based on FFQ;

14. Has an active gastrointestinal disorder or previous gastrointestinal surgery,

15. If taking chronic medications (e.g., anti-hypertensive medications), they must have been taking the product for at least two months prior to screening and agree to maintain the same dosage throughout the study;

16. Has a metabolic, psychiatric, or gastrointestinal disease (i.e., diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, diabetes, hepatitis, HIV, cancer, etc.), with a history of such diseases;

17. Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year);

18. Experiences alarm features such as weight loss, rectal bleeding, recent change in bowel habit (<3 months) or abdominal pain;

19. Have a malignant disease or any concomitant end-stage organ disease;

20. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial;

21. Subjects may not be receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role: collaborator

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Dinan, Prof

Role: PRINCIPAL_INVESTIGATOR

Cork University Hospital

Locations

Atlantia

Cork, Blackpool Cork, Ireland

Countries

Ireland

References

Pham VT, Fehlbaum S, Seifert N, Richard N, Bruins MJ, Sybesma W, Rehman A, Steinert RE. Effects of colon-targeted vitamins on the composition and metabolic activity of the human gut microbiome- a pilot study. Gut Microbes. 2021 Jan-Dec;13(1):1-20. doi: 10.1080/19490976.2021.1875774.

Reference Type: DERIVED

PMID: 33615992 (View on PubMed)

Other Identifiers

2017-12-19-VIT

Identifier Type: -

Identifier Source: org_study_id